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A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

NCT ID: NCT01352793

Last Updated: 2015-03-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5715 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-09-30

Brief Summary

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A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

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Detailed Description

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Conditions

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Meningitis, Meningococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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rLP2086 vaccine

rLP2086 vaccine

Group Type EXPERIMENTAL

rLP2086 vaccine

Intervention Type BIOLOGICAL

120 mcg, 3 doses, at month 0, 2, and 6.

control

The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.

Group Type OTHER

control

Intervention Type BIOLOGICAL

HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.

Interventions

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rLP2086 vaccine

120 mcg, 3 doses, at month 0, 2, and 6.

Intervention Type BIOLOGICAL

control

HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects aged 10 to 25 years.

Exclusion Criteria

* Previous vaccination with Hepatitis A virus vaccine
* Previous vaccination with investigational meningococcal B vaccine
* History of culture-proven N. meningitidis serogroup B disease
* Any neuroinflammatory or autoimmune condition
* Any immune defect that would prevent an effective response to the study vaccine
Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Accelovance,Inc.

Huntsville, Alabama, United States

Site Status

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC

Chandler, Arizona, United States

Site Status

Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC

Chandler, Arizona, United States

Site Status

Cassidy Medical Group/Clinical Research Advantage

Tempe, Arizona, United States

Site Status

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC

Tempe, Arizona, United States

Site Status

Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address

Tempe, Arizona, United States

Site Status

Harrisburg Family Medical Center

Harrisburg, Arkansas, United States

Site Status

Accelovance. Inc

San Diego, California, United States

Site Status

Benchmark Research

San Francisco, California, United States

Site Status

Cassidy Medical Group/Clinical Research Advantage

Vista, California, United States

Site Status

Avail Clinical Research, LLC

DeLand, Florida, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Optimal Research, LLC

Melbourne, Florida, United States

Site Status

Accelovance

Melbourne, Florida, United States

Site Status

Miami Research Associates

South Miami, Florida, United States

Site Status

Accelovance,Inc.

Mishawaka, Indiana, United States

Site Status

Clinical Research Advantage,Inc/Ridge Family Practice

Council Bluffs, Iowa, United States

Site Status

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, United States

Site Status

Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP

Fremont, Nebraska, United States

Site Status

Prairie Fields Family Medicine/Clinical Research Advantage

Fremont, Nebraska, United States

Site Status

Rochester Clinical Research, Inc.

Rochester, New York, United States

Site Status

Rapid Medical Research. Inc.

Cleveland, Ohio, United States

Site Status

Ohio Pediatric Research Association

Dayton, Ohio, United States

Site Status

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Site Status

PMG Research of Bristol

Bristol, Tennessee, United States

Site Status

Benchmark Research

Austin, Texas, United States

Site Status

Tekton Research

Austin, Texas, United States

Site Status

Research Across America

Dallas, Texas, United States

Site Status

Benchmark Research

Fort Worth, Texas, United States

Site Status

West Houston Clinical Research Service

Houston, Texas, United States

Site Status

Research Across America

Katy, Texas, United States

Site Status

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

J. Lewis Research, Inc. - Foothill Family Clinic

Salt Lake City, Utah, United States

Site Status

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, United States

Site Status

Jean Brown Research

Salt Lake City, Utah, United States

Site Status

J. Lewis Research, Inc. - Jordan River Family Medicine

South Jordan, Utah, United States

Site Status

Advanced Clinical Research

West Jordan, Utah, United States

Site Status

PI-Coor Clinical Research, LLC

Burke, Virginia, United States

Site Status

Pediatric Research of Charlottesville

Charlottesville, Virginia, United States

Site Status

Australian Clinical Research Network

Maroubra, New South Wales, Australia

Site Status

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Site Status

AusTrials Pty Ltd

Sherwood, Queensland, Australia

Site Status

Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics

North Adelaide, South Australia, Australia

Site Status

Telethon Institute for Child Health Research

Subiaco, , Australia

Site Status

Centro De Investigacion Clinica Del Sur

Temuco, Región de la Araucanía, Chile

Site Status

Cesfam Dr. Jose Symon Ojeda

Conchalí, Santiago Metropolitan, Chile

Site Status

Hospital Clinico de la Pontificia Universidad Catolica de Chile/

Santiago, Santiago Metropolitan, Chile

Site Status

Centro de Estudios de Vacunas, CESFAM Gabriela Mistral

Santiago, Santiago Metropolitan, Chile

Site Status

Hospital Luis Calvo Mackenna

Santiago, , Chile

Site Status

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, , Czechia

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, , Czechia

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, , Czechia

Site Status

Ordinace praktickeho lekare pro deti a dorost

Pilsen, , Czechia

Site Status

Ordinace praktickeho lekare pro deti a dorost

Prague, , Czechia

Site Status

Prakticky Lekar Pro Deti a Mladez

Týnec nad Sázavou, , Czechia

Site Status

Aarhus Universitetshospital, Skejby

Aarhus N, , Denmark

Site Status

Eraarst Kersti Veidrik Ou

Rakvere, , Estonia

Site Status

Innomedica OU

Tallinn, , Estonia

Site Status

Merekivi Perearstid OU

Tallinn, , Estonia

Site Status

Merelahe Family Doctors Centre

Tallinn, , Estonia

Site Status

Pori Vaccine Research Clinic

Pori, , Finland

Site Status

Tampere Vaccine Research Clinic

Tampere, , Finland

Site Status

Turku Vaccine Research Clinic

Turku, , Finland

Site Status

Clinical Trial Center North

Hamburg, , Germany

Site Status

Clinical Trial Center North GmbH & Co.KG

Hamburg, , Germany

Site Status

Bernhard Nocht Centre for Clinical Trials (BNCCT)

Hamburg, , Germany

Site Status

Juliusspital Wuerzburg

Würzburg, , Germany

Site Status

JSC "InMedica"

Kaunas, , Lithuania

Site Status

Saules Family Medicine Centre

Kaunas, , Lithuania

Site Status

Kaunas Clinical Hospital, Public Institution, Clinic of Infectious Diseases

Kaunas, , Lithuania

Site Status

LITHUANIAN HEALTH SCIENCE UNIVERSITY HOSPITAL, CLINIC of FAMILY MEDICINE

Kaunas, , Lithuania

Site Status

Centro poliklinika, Public Institution

Vilnius, , Lithuania

Site Status

Krakowski Szpital Specjalistyczny im Jana Pawla II

Krakow, Poland, Poland

Site Status

Prywatny Gabinet Lekarski Dr.n.med.Jerzy Brzostek

Dębica, , Poland

Site Status

Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska

Krakow, , Poland

Site Status

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny

Lubartów, , Poland

Site Status

NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak

Oborniki Śląskie, , Poland

Site Status

Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu

Poznan, , Poland

Site Status

NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, , Poland

Site Status

NZOZ Nasz Lekarz

Torun, , Poland

Site Status

Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny

Trzebnica, , Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

Wroclaw, , Poland

Site Status

Instituto Hispalense de Pediatria

Seville, Sevilla, Spain

Site Status

Clinicas Universitarias. Universidad Catolica de Valencia San Vicente Martir

Valencia, Valencia, Spain

Site Status

Vaccinenheten Barn- och ungdomsmedicinska kliniken

Malmo, SE, Sweden

Site Status

Norrlands Universitetssjukhus, Institution för Pediatrik

Umeå, , Sweden

Site Status

Countries

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United States Australia Chile Czechia Denmark Estonia Finland Germany Lithuania Poland Spain Sweden

References

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Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.

Reference Type DERIVED
PMID: 35164991 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1971014&StudyName=A%20Global%20Phase%203%20Safety%20Study%20of%20120%20mcg%20rLP2086%20Vaccine%20in%20Adolescents%20and%20Young%20Adults%20Aged%2010%20to%2025%20Years

To obtain contact information for a study center near you, click here.

Other Identifiers

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2009-015198-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

6108A1-3003

Identifier Type: OTHER

Identifier Source: secondary_id

B1971014

Identifier Type: -

Identifier Source: org_study_id

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